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NCT00519077 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT00519077: Completed Phase 2 study, sponsored by University of Chicago.
NCT00519077 is a Phase 2 study that has completed, run by University of Chicago. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00519077, a Phase 2 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the activity (response rate and rate of stable disease) of Iressa administered as a single agent escalated to a dose that produces grade 2 skin toxicity in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Primary Outcome
The proportion of subjects that responded \[complete (CR) or partial response (PR)\], had stable disease (SD), or progressive disease (PD) as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor
Interventions
- DRUG Gefitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2005-03 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT00519077 record still lists
NCT00519077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Gefitinib is the first listed.
NCT00519077 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00519077 about?
NCT00519077 is a clinical study titled "Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck". The purpose of this study is to demonstrate the activity (response rate and rate of stable disease) of Iressa administered as a single agent escalated to a dose that produces grade 2 skin toxicity in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
What is the current status of trial NCT00519077?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2005-03. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00519077?
The interventions under investigation include: Gefitinib (DRUG).
Who is sponsoring clinical trial NCT00519077?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00519077's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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